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Phase I clinical study for immunotherapy using neoantigen reactive tumor infiltrating lymphocytes for patients with kidney cancer

Phase I clinical study for immunotherapy using neoantigen reactive tumor infiltrating lymphocytes for patients with kidney cancer

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017934
Enrollment
Unknown
Registered
2018-08-23
Start date
2018-08-13
Completion date
Unknown
Last updated
2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney cancer

Interventions

Case series:neoantigen reactive tumor infiltrating lymphocytes

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years; 2. Histopathologically diagnosed as kidney cancer; 3. Availability of tumor tissue; 4. ECOG PS: 0-2; 5. Hematology Index including: Neutrophile granulocyte greater than 1.5×10^9/L, hemoglobin greater than 10g/dL and platelet greater than 100×10^9/L; 6. Life expectancy of greater than six months; 7. No active infection within two weeks; 8. Physician plans to use TIL treatment; 9. Consent to participate in clinical trials, Having full capacity for civil conduct.

Exclusion criteria

Exclusion criteria: 1. Analysis of gene sequencing data has not found enough neoantigens for subsequent treatment; 2. Patients with heart failure and severe pulmonary dysfunction; 3. Patients with autoimmune disease and immunosuppressive agents or hormone therapy; 4. Patients with serious uncontrolled infection, or other serious uncontrolled concomitant disease; 5. Patients with HIV and syphilis infection. 6. Patients whose genotype of Human leukocyte antigen (HLA) is homozygous or lacking alleles 7. Patients with Prior treatment using immuno-checkpoints inhibitor; 8. Patients with allergy to any interferon, interleukin 2; 9. Pregnancy or nursing females; 10. Patients with primary immunodeficiency or major organ autoimmune disease 11. T cell-associated lymphoma and leukemia patients; 12. Physicians believe that patients are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
progression-free survival;the rate of disease control;

Secondary

MeasureTime frame
Overall survival;

Countries

China

Contacts

Public ContactWeiren Huang

Shenzhen Second People's Hospital

pony8980@163.com+86 13923781386

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026